Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC)

This Directive shall apply to active implantable medical devices.

For the purposes of this Directive, the following definitions shall apply:

1. ‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

   • diagnosis, prevention, monitoring, treatment or alleviation of disease,

   • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

   • investigation, replacement or modification of the anatomy or of a physiological process,

   • control of conception,

   and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

2. ‘active medical device’ means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity;

3. ‘active implantable medical device’ means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure;

4. ‘custom-made device’ means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient. Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom-made devices;

5. ‘device intended for clinical investigation’ means any device intended for use by a duly qualified medical practitioner when conducting clinical investigations as referred to in Section 2.1 of Annex 7 in an adequate human clinical environment.

   For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorised to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;

6. ‘intended purpose’ means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional material;

7. ‘putting into service’ means making available to the medical profession for implantation;

8. ‘placing on the market’ means the first making available in return for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished;

9. ‘manufacturer’ means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.

   The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient;

10. ‘authorised representative’ means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;

11. ‘clinical data’ means the safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:

    • clinical investigation(s) of the device concerned, or

    • clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or

    • published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.

Where an active implantable medical device is intended to administer a substance defined as a medicinal product within the meaning of Article 1 of Directive 2001/83/EC⁽⁶⁾, that device shall be governed by this Directive, without prejudice to the provisions of Directive 2001/83/EC with regard to the medicinal product.

Where an active implantable medical device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action that is ancillary to that of the device, that device shall be evaluated and authorised in accordance with this Directive.

Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning of Article 1 of Directive 2001/83/EC and which is liable to act upon the human body with action that is ancillary to that of the device, hereinafter referred to as a ‘human blood derivative’, that device shall be assessed and authorised in accordance with this Directive.

This Directive constitutes a specific Directive within the meaning of Article 1(4) of Directive 2004/108/EC⁽⁷⁾.

This Directive shall not apply to:

1. medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;

2. human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells with the exception of devices referred to in paragraph 4a;

3. transplants or tissues or cells of human origin or to products incorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a;

4. transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.

Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices complying with the provisions of this Directive and bearing the CE marking provided for in Article 12, which indicates that they have been the subject of an assessment of their conformity in accordance with Article 9.

Member States shall not create any obstacles to:

• devices intended for clinical investigations being made available to duly qualified medical practitioners or authorised persons for that purpose if they satisfy the conditions laid down in Article 10 and in Annex 6,

• custom-made devices being placed on the market and put into service if they satisfy the conditions laid down in Annex 6 and are accompanied by the statement, which shall be available to the particular identified patient, referred to in that Annex.

These devices shall not bear the CE marking.

At trade fairs, exhibitions, demonstrations, etc., Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that a visible sign clearly indicates that such devices do not conform and cannot be marketed or put into service until they have been made to comply by the manufacturer or his authorised representative.

When a device is put into service, Member States may require the information described in sections 13, 14 and 15 of Annex 1 to be in their national language(s).

1. Where the devices are subject to other Directives concerning other aspects and which also provide for the affixing of the CE marking, the latter shall indicate that the devices are also presumed to conform to the provisions of the other Directives.

2. However, where one or more of these Directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking shall indicate conformity to the provisions only of those Directives applied by the manufacturer. In this case, particulars of the Directives applied, as published in the Official Journal of the European Communities, must be given in the documents, notices or instructions required by the Directives and accompanying such devices; these documents, notices or instructions shall be accessible without it being necessary to destroy the packaging which keeps the device sterile.